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November 26, 2013 By: galadmin

Ethicon Ordered to Produce Documents Relating to Predicate Devices

Magistrate Judge E. Thomas, a Florida federal judge, has ordered Ethicon Inc. to produce documents related to predicate devices in a lawsuit with one of their products, the Contour Curved Cutter Stapler.

The U.S. District Court for the Middle District of Florida judge could not find a reason to prevent the plaintiff from receiving these documents, as they are relevant to his case.

Magistrate Judge Morris added that Ethicon had informed the U.S. Food and Drug Administration (FDA) that these devices are “substantially equivalent” to the surgical stapler at issue in this lawsuit. “Substantial equivalency between a product and its predicate devices can be established by comparing ‘materials, design consideration, energy expected to be used or delivered by the device,’ and operational principles, as well as device functions, scientific bases, and performance characteristics,” he continued. “It is likely that documents pertaining to the Contour Stapler’s predicate devices are relevant insofar as discovery for the documents is reasonably calculated to lead to admissible evidence.”

The plaintiff in this case, Leander McLane, brought a lawsuit against Ethicon Endo-Surgery Inc., alleging that it’s Contour Curved Cutter Stapler (Model CR40G) and/or stapler reloads (Model CR40G) used during his colon resection surgery back in May 2010 were defective and/or faulty.

McLane contends that these faulty devices lead to permanent injuries and damages; specifically, that the device failed to implant any of the titanium staples in his colon, which resulted in the surgeon being unable to salvage the rectal stump. As a result, McLane was left with a permanent colostomy, as the surgeon could not finish the surgery.

As McLane and his attorney were preparing this case for trial, they were looking for documents possessed by Ethicon which determined whether Ethicon knew or should have known about the adverse events caused as a result of the Contour Stapler, as well as its predicate devices.

Ethicon responded by asserting that McLane was not entitled to documents that related to the predicate devices, as those devices were not used in McLane’s surgery. They added that information about the predicate devices would not assist McLane’s experts in reaching opinions as to any alleged defects in the Contour Stapler.

Magistrate Judge Morris ruled that Ethicon failed to meet its burden of showing specifically how these documents are irrelevant. He added that when Ethicon presented these predicate devices to the FDA, they identified them as “substantially equivalent”. He stated, “Ethicon now refuses to produce the documents designated for production. This court will remind Ethicon that discovery is intended to operate with minimal judicial supervision. Furthermore, ‘discovery in this district should be practiced with a spirit of cooperation and civility.’”

Do you agree with Ethicon in that they should not have to produce these documents, or do you agree with the Judge, who is requiring them to produce the documents for the plaintiff? For more information, contact a Gacovino Lake attorney at 1-800-246-HURT (4878).

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